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U.S. Department of Health and Human Services

Class 2 Device Recall H. pylori (polyclonal)

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  Class 2 Device Recall H. pylori (polyclonal) see related information
Date Initiated by Firm May 05, 2017
Date Posted June 01, 2017
Recall Status1 Terminated 3 on September 07, 2017
Recall Number Z-2202-2017
Recall Event ID 77209
Product Classification Immunohistochemical assay, Helicobacter pylori - Product Code OWF
Product H. pylori (polyclonal}
1.0 mL Catalog number 215A-76;

Hematology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent
Code Information 1.0 ml lot 1611307C, expiry 201 9-03. 
Recalling Firm/
Cell Marque Corporation
6600 Sierra College Blvd
Rocklin CA 95677-4306
For Additional Information Contact Veronica Runyan
Manufacturer Reason
for Recall
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
FDA Determined
Cause 2
Labeling mix-ups
Action Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.
Quantity in Commerce 5
Distribution Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.